DL-Citrulline Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials investigate citrulline supplementation and related metabolic interventions for diverse indications, including bronchopulmonary dysplasia, pulmonary hypertension, type 2 diabetes mellitus, postmenopausal hypertension, and chemotherapy-induced toxicities such as mucositis and peripheral neuropathy. Spanning Early Phase 1 through unassigned or non-applicable protocols, trial recruitment statuses range from active recruitment and enrollment by invitation to protocols not yet recruiting. These studies are sponsored by academic and clinical institutions, including The Hospital for Sick Children, Texas Tech University, Tanta University, and Wuhan Union Hospital.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06207461	Not yet recruiting	Traditional Chinese Acupoint Message\|Intestinal Barrier\|Gastrointestinal Dysfunction	Wuhan Union Hospital China	2024-02-15	--
NCT05636397	Recruiting	BPD - Bronchopulmonary Dysplasia\|Pulmonary Hypertension\|NEC	The Hospital for Sick Children	2023-11-01	Not Applicable
NCT06092476	Not yet recruiting	Diabetes Mellitus Type 2	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)\|Fractyl Health Inc.	2023-11-01	Not Applicable
NCT06025383	Recruiting	Menopause\|Hypertension	Texas Tech University	2023-07-20	Not Applicable
NCT05590117	Enrolling by invitation	Colo-rectal Cancer\|Neuropathy;Peripheral\|Mucositis	Tanta University	2022-10-11	Early Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the DL-Citrulline product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

DL-Citrulline serves as a key intermediate in the urea cycle and an endogenous precursor for L-arginine synthesis, which stimulates endothelial nitric oxide synthase to produce nitric oxide and elevate intracellular cyclic GMP levels, resulting in vascular smooth muscle relaxation. This enhancement of nitric oxide bioavailability and microvascular perfusion provides the mechanistic basis for its clinical evaluation in pulmonary hypertension, postmenopausal vascular dysfunction, and mucosal tissue recovery.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).